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DFL24498 in Dry Eye Disease
NCT07503886Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2026
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Dompé
- Modality
- Small Molecules
- Drugs
- isocyclosporin
- Conditions
- dry eye disease (DED)
01
Overview
Phase 2, randomised, double-blind trial in dry eye disease (DED) comparing DFL24498 with Vehicle (2 arms). Primary endpoint: Corneal Fluorescein Staining at 12 weeks. Started May 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
DFL24498
DFL24498 ophthalmic solution administered topically in both eyes
Vehicle
Vehicle ophthalmic solution administered topically in both eyes
03
Who it enrols
Adults with a diagnosis of Dry Eye Disease for at least 6 months, SANDE score >= 30, Schirmer I < 10 mm/5 min, Total CFS grade >= 4, TFBUT < 10s, and BCVA >= 35 letters. Excludes patients with active ocular infection, anticipated/recent ocular surgery, intraocular inflammation, or ocular malignancy.
04
Endpoints
Primary
Corneal Fluorescein Staining
Secondary
Symptom Assessment in Dry Eye
Schirmer I Test
Conjunctival Fluorescein Staining
Treatment-Emergent Adverse Events
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